QA Specialist - Validation & Data Integrity L. 68/99

Posted 29 Feb 2024

Guidonia Montecelio, Rome - Italy

Req Id 272462

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


 

Your Role:

 

An exciting new opportunity has arisen within Healthcare Quality. We are looking for a full-time experienced Quality Assurance specialist on computerized system validation and data integrityIn this role you will be in change to ensuring that computer systems used in regulated environments comply with regulatory requirements, writing and overseeing the quality assurance processes related to software systems in regulated environment. This includes ensuring that systems adhere to regulatory standards, validating software systems to ensure accuracy and reliability, implementing measures to maintain data integrity and security, and applying AI principles to optimize quality assurance processes and identify areas for improvement. Collaborate on the evaluation of the changes to the computerized systems from a regulation and data integrity requirements perspective; Verify if a computerized system is designed according to the applicable regulatory and data integrity requirements: review of User Requirements and Software Specifications. You would likely closely with cross-functional teams to develop validation protocols, conduct risk assessments, and provide guidance and training on compliance standards and best practices. You will collaborate with internal/supplier audit team during audit in GAMP area.

 

Who you are:

 

  • Master’s Degree in Technical scientifical field or equivalent
  • At least 3 years of experience in pharmaceutical industry
  • General knowledge of GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211)
  • Fluent in spoken and written English
  • Previous experience in complex organizations and international networks is in CSV/digital quality assurance
  • Experiences in Quality area with knowledge on:
    • Computer systems related quality processes (e.g. Change Control, Deviation, CAPA);
    • Computerized system to analytical laboratory (e.g. CDS, LIMS)
    • GAMP guidance
    • GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211)
    • Data governance and data Integrity principles
  • Problem solving and team working
  • Precision and control
  • Flexibility: planning and organizing
  • Proactively identify areas for improvement within Quality Systems
  • Knowledge of root cause analysis methodology, Lean Six Sigma and Quality Risk Management


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!


US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


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